FDA WARNING_LETTER - Mrs Wheat's Foods Fabulous Foods, Inc. - May 16, 2014

On May 7, 8, and 16, 2014, the FDA inspected Mrs. Wheat's Fabulous Foods, Inc. in New Orleans, Louisiana, and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Parts 110 and 123). The firm's crawfish pies are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations include: 1. Failure to implement monitoring, recordkeeping, and verification procedures for the "Thawing of crawfish tail meat" Critical Control Point (CCP), specifically not monitoring the temperature during thawing. 2. Failure of the "Cool pie filling mix" CCP to list a critical limit that effectively controls the growth and toxin formation of *Bacillus cereus* and *Staphylococcus aureus*. The current critical limit does not ensure proper cooling from 135°F to 70°F within two hours, and from 70°F to 40°F within an additional four hours. 3. Failure of the HACCP plan to list finished product labeling as a CCP to control for undeclared major food allergens (crustacean shellfish). 4. Failure to annually sign and date the HACCP plan.

The FDA warns of potential further action, including product seizure